Ekos has reported that it is in the final planning and approval stages of a randomized clinical study for the treatment of pulmonary embolism, known as the ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA) study. The company will use its EkoSonic endovascular device while conducting the trial.
Serious pulmonary emboli interfere with the heart’s ability to pump blood into the lungs for oxygenation, causing enlargement of the right side of the heart, and potentially causing death.
Robert Hubert, president and CEO of Ekos, said: “We are pleased to announce that Dr. Nils Kucher, an internationally known expert on pulmonary embolism, University Hospital (Bern, Switzerland), will be the principle investigator for the study. Dr. Kucher will be joined by colleagues from the University Hospitals in Dresden, Munich and Greifswald, Germany, and several other sites.”
Dr. Kucher said: “This study is, to our knowledge, the first randomized controlled trial designed to show the clinical benefit of an endovascular device to treat acute sub massive pulmonary embolism in comparison to anticoagulation therapy alone.
“We intend to show that treatment with low-dose, ultrasound accelerated thrombolysis [EKOS] will improve right heart failure in these patients, without introducing the risks associated with systemic thrombolytic therapy.”
Mr. Hubert added: “In the ULTIMA study, 50 patients with pulmonary embolism and enlarged right hearts will be randomized to receive either standard of care anti-coagulation or Actilyse (Boehringer Ingleheim) delivered via the EKOS EkoSonic Endovascular Device. The amount of drug necessary to dissolve a blood clot is reduced when using the EKOS system because ultrasound increases the permeability of the clot while driving the drug into its interior.
“We anticipate that delivery of Actilyse directly into the pulmonary embolism in the presence of the ultrasound generated by the EkoSonic Device will result in prompt, complete dissolution of the obstructing embolism with restoration of right heart function and a reduction in the number of patients with long-term side effects from their pulmonary embolism.”
Enrollment is expected to commence in the first quarter of 2010 and be completed by the first quarter of 2011.